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Providing Patients Realistic Expectations of Postoperative Pain (PPREOPP)

Primary Purpose

Pain, Postoperative

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 years
  • Undergoing open colorectal surgery Able to understand and sign and informed consent form

Exclusion Criteria:

  • Age < 18 years
  • Unable to complete post-operative CMS questionnaire
  • Inability to understand the English language Absolute contraindication to epidural placement (patient refusal, requiring resumption of therapeutic anticoagulation after surgery, anaphylaxis to local anesthetics, local or systemic infections, bleeding diathesis)

Sites / Locations

  • Washington University in St. Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Education

Arm Description

Standard preoperative assessment

Pre-operative education regarding post-operative pain expectations

Outcomes

Primary Outcome Measures

Does perioperative education improve satisfaction with postoperative pain control at discharge?
The satisfaction with postoperative pain control will be assessed using an initial, post-operative and discharge questionnaire of participant's pain level, medications (if any) to manage pain, the affects of that pain management, and participant satisfaction of that pain control.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2017
Last Updated
August 24, 2018
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03434847
Brief Title
Providing Patients Realistic Expectations of Postoperative Pain
Acronym
PPREOPP
Official Title
The PPREOPP Study: Providing Patients Realistic Expectations of Postoperative Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
CMS questions to assess patient satisfaction of pain control were removed from the HCAHPS survey, leaving the study without intervention assessment.
Study Start Date
October 21, 2017 (Actual)
Primary Completion Date
January 16, 2018 (Actual)
Study Completion Date
January 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Prospective, randomized, single-blind study, whether perioperative educational improves pain-related postoperative outcomes,
Detailed Description
This is a prospective, randomized, single-blind study in 100 patients undergoing open colorectal surgery. If the hypothesis is confirmed, then patients who receive perioperative educational interventions to address their expectation about their postoperative pain will have improved pain-related postoperative outcomes. Randomization and Blinding 100 eligible patients scheduled to undergo open colorectal surgery will be approached in the Center for Preoperative Assessment and Planning Clinic. At enrollment, each patient will be assigned a study number, which will match a previously prepared computer-generated list of randomization numbers to determine whether they will be in the intervention or control arm. Pre-operatively, all patients will complete an initial questionnaire. The patients in the intervention group (n=50) will, in addition to the standard pre-operative assessment, also receive pre-operative educational instruction of what to expect from a post-operative pain perspective including education material to take home. For this study, deception will be used, with the reasoning that the patients' knowledge of the different education materials will affect their rating of the impact of the intervention on satisfaction scores.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, single-blind study
Masking
Participant
Masking Description
At enrollment, each patient will be assigned a study number, which will match a previously prepared computer-generated list of randomization numbers to determine whether they will be in the intervention or control arm. Pre-operatively, all patients will complete an initial questionnaire. The patients in the intervention group (n=50) will, in addition to the standard pre-operative assessment, also receive pre-operative educational instruction of what to expect from a post-operative pain perspective including education material to take home. For this study, we will be using deception, with the reasoning that the patients' knowledge of the different education materials will affect their rating of the impact of the intervention on satisfaction scores.
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard preoperative assessment
Arm Title
Education
Arm Type
Active Comparator
Arm Description
Pre-operative education regarding post-operative pain expectations
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Participants who receive perioperative educational to address their expectation about their postoperative pain will have improved pain-related postoperative outcomes.
Primary Outcome Measure Information:
Title
Does perioperative education improve satisfaction with postoperative pain control at discharge?
Description
The satisfaction with postoperative pain control will be assessed using an initial, post-operative and discharge questionnaire of participant's pain level, medications (if any) to manage pain, the affects of that pain management, and participant satisfaction of that pain control.
Time Frame
Upon discharge, Day 1 - Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years Undergoing open colorectal surgery Able to understand and sign and informed consent form Exclusion Criteria: Age < 18 years Unable to complete post-operative CMS questionnaire Inability to understand the English language Absolute contraindication to epidural placement (patient refusal, requiring resumption of therapeutic anticoagulation after surgery, anaphylaxis to local anesthetics, local or systemic infections, bleeding diathesis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Bottros, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24858373
Citation
Koenen P, Bathis H, Schneider MM, Frohlich M, Bouillon B, Shafizadeh S. How do we face patients' expectations in joint arthroplasty? Arch Orthop Trauma Surg. 2014 Jul;134(7):925-31. doi: 10.1007/s00402-014-2012-x. Epub 2014 May 24.
Results Reference
background
PubMed Identifier
22821348
Citation
Ghomrawi HM, Mancuso CA, Westrich GH, Marx RG, Mushlin AI; Expectations Discordance Study Group. Discordance in TKA expectations between patients and surgeons. Clin Orthop Relat Res. 2013 Jan;471(1):175-80. doi: 10.1007/s11999-012-2484-3.
Results Reference
background
PubMed Identifier
24787107
Citation
Waljee J, McGlinn EP, Sears ED, Chung KC. Patient expectations and patient-reported outcomes in surgery: a systematic review. Surgery. 2014 May;155(5):799-808. doi: 10.1016/j.surg.2013.12.015. Epub 2013 Dec 16.
Results Reference
background
PubMed Identifier
10376227
Citation
Shuldham C. A review of the impact of pre-operative education on recovery from surgery. Int J Nurs Stud. 1999 Apr;36(2):171-7. doi: 10.1016/s0020-7489(99)00010-3.
Results Reference
background
PubMed Identifier
15920209
Citation
Snyder-Ramos SA, Seintsch H, Bottiger BW, Motsch J, Martin E, Bauer M. Patient satisfaction and information gain after the preanesthetic visit: a comparison of face-to-face interview, brochure, and video. Anesth Analg. 2005 Jun;100(6):1753-1758. doi: 10.1213/01.ANE.0000153010.49776.E5.
Results Reference
background
PubMed Identifier
27746541
Citation
Kaur H, Singh G, Singh A, Sharda G, Aggarwal S. Evolving with modern technology: Impact of incorporating audiovisual aids in preanesthetic checkup clinics on patient education and anxiety. Anesth Essays Res. 2016 Sep-Dec;10(3):502-507. doi: 10.4103/0259-1162.177187.
Results Reference
background
PubMed Identifier
26097859
Citation
Noorian C, Aein F. Comparative investigation of the effectiveness of face-to-face verbal training and educational pamphlets on readiness of patients before undergoing non-emergency surgeries. J Educ Health Promot. 2015 May 19;4:45. doi: 10.4103/2277-9531.157231. eCollection 2015.
Results Reference
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Links:
URL
http://www.hcahpsonline.org
Description
HCAHPS Patient Level Correlations

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Providing Patients Realistic Expectations of Postoperative Pain

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